The study aims to develop and test the effectiveness of a new home-based pulmonary rehabilitation program comprising two distinct phases, the first in which an 8-week respiratory rehabilitation program is carried out the second in which a maintenance pulmonary rehabilitation program is carried out.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
160
Continuous educational support, exercise training, behaviour change intervention, and self-management. Maintenance home-based pulmonary rehabilitation programme for ten months with alternate supervision
No maintenance programme, and the patient has the usual follow-up and medical appointments
Unidade Local de Saúde de Matosinhos
Matosinhos Municipality, Porto District, Portugal
RECRUITINGDistance in meters covered over a time of 6 minutes 0
Distance in meters covered over a time of 6 minutes 0 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Time frame: Baseline
Distance in meters covered over a time of 6 minutes 1
Distance in meters covered over a time of 6 minutes 1 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Time frame: 8 weeks
Distance in meters covered over a time of 6 minutes 2
Distance in meters covered over a time of 6 minutes 2 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Time frame: 7 months
Distance in meters covered over a time of 6 minutes 3
Distance in meters covered over a time of 6 minutes 3 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Time frame: 12 months
Dyspnoea 0
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
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Time frame: Baseline
Dyspnoea 1
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
Time frame: 8 weeks
Dyspnoea 2
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
Time frame: 7 months
Dyspnoea 3
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
Time frame: 12 months
Health-Related Quality of Life 0
European quality of life-5 dimensions (EQ5D)
Time frame: Baseline
Health-Related Quality of Life 1
European quality of life-5 dimensions (EQ5D)
Time frame: 8 weeks
Health-Related Quality of Life 2
European quality of life-5 dimensions (EQ5D)
Time frame: 7 months
Health-Related Quality of Life 3
European quality of life-5 dimensions (EQ5D)
Time frame: 12 months
Number of emergency department visits due to COPD exacerbation 0
Number of exacerbations (accessing to emergency department)
Time frame: Baseline
Number of emergency department visits due to COPD exacerbation 1
Number of exacerbations (accessing to emergency department)
Time frame: 8 weeks
Number of emergency department visits due to COPD exacerbation 2
Number of exacerbations (accessing to emergency department)
Time frame: 7 months
Number of emergency department visits due to COPD exacerbation 3
Number of exacerbations (accessing to emergency department)
Time frame: 12 months
COPD symptom control 0
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
Time frame: Baseline
COPD symptom control 1
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
Time frame: 8 weeks
COPD symptom control 2
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
Time frame: 7 months
COPD symptom control 3
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
Time frame: 12 months
Anxiety and Depression 0
Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score \>8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring
Time frame: Baseline
Anxiety and Depression 1
Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score \>8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring
Time frame: 8 weeks
Anxiety and Depression 2
Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score \>8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring
Time frame: 7 months
Anxiety and Depression 3
Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score \>8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring
Time frame: 12 months
Physical activity 0
Counting steps per day with the pedometer Yamax EX510
Time frame: Baseline
Physical activity 1
Counting steps per day with the pedometer Yamax EX510
Time frame: 8 weeks
Physical activity 2
Counting steps per day with the pedometer Yamax EX510
Time frame: 7 months
Physical activity 3
Counting steps per day with the pedometer Yamax EX510
Time frame: 12 months
Functional capacity 0
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height
Time frame: Baseline
Functional capacity 1
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height
Time frame: 8 weeks
Functional capacity 2
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height
Time frame: 7 months
Functional capacity 3
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height
Time frame: 12 months